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Strategic Consulting

Puzzling Elements.

Consulting vs. Strategic Consulting?

WI works with a variety of pharmaceutical, biotechnical, and device corporations. We have seen some impressive processes as well as some approaches that we wouldn't necessarily recommend.  Reading up on regulatory changes, reviewing updates to guidance documents, and attending in-service trainings and industry conferences is encouraged and expected of all WI writers. What are your best practices?  Schedule a conversation with WI and we’ll reveal the right way to produce perfect scientific, clinical, and CMC regulatory documents. Whether you need help in clinical regulatory, CMC regulatory, publications, or pharmacovigilance, WI is the supplier of choice for strategic consulting, collaboration, and well-written documentation. Our expertise includes:
  • Dossier Strategy/Submission Planning
  • Gap analysis of CMC technical package for submission into new markets
  • Clinical Development Plans
  • Process Consultation
  • Publication Planning Strategy
  • Comprehensive Product Risk Assessment and Hazard Evaluation by MD and PharmD Reviewers